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Clinical evaluation of the addition of antifungal drugs to denture liner material in the treatment of oral candidiasis

Clinical evaluation of the addition of antifungals to temporary resilient liner in the denture stomatitis treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9yjjxvq
Enrollment
Unknown
Registered
2022-03-21
Start date
2015-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candida

Interventions

The sample of this study involved patients using conventional upper complete denture with denture stomatitis on the palatal denture-bearing mucosa, attended in the Prosthodontics Clinic of the Bauru S
D02.078.370.141.100

Sponsors

Karin Hermana Neppelenbroek
Lead Sponsor
Faculdade de Odontologia de Bauru - Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Volunteer users of conventional removable upper denture; clinical diagnosis for denture stomatitis in the palatal mucosa supporting the complete denture, both genders, any age, regardless of the condition of the mandibular arch and the use and status of the lower denture.

Exclusion criteria

Exclusion criteria: Volunteers with anemia; immunocompromised; with uncontrolled endocrinopathologies; in a therapeutic regimen with antibiotics, steroids or antifungals in the last three months; under antineoplastic treatment by radio or chemotherapy; users of the same upper complete denture for over 30 years

Design outcomes

Primary

MeasureTime frame
Primary outcome 1: Reduction of mycelial forms of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by cytological examinations by smears obtained from these areas, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of treatment discontinuation), of at least a 30% improvement in palatal smears as well as a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment on the prosthetic smears.;Primary outcome 2: Reduction in the values of colony forming units per milliliter of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by means of quantitative mycological cultures, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of suspension of the treatment) of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment in cultures of both palate and prosthesis areas. ;Primary outcome 3: Reduction of clinical severity of denture stomatitis, verified by means of standardized photographs of the palatal mucosa affected by the lesion, from the observation, at the end of treatment (14 days) and at the end of the experimental period (60 days after suspension of treatment), of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of the treatment.

Secondary

MeasureTime frame
Secondary outcome 1: Assess whether the main general and local factors associated with Candida proliferation (patient's age and sex, age and nighttime use of current dentures, smoking, the type of denture stomatitis according to Newton, the use of xerostomia-inducing drugs, presence of xerostomia and poor oral and prosthesis hygiene habits) were present in most volunteers, through anamnesis, clinical examination and examination of the prosthesis, to verify their influence as predisposing factors to denture stomatitis.

Countries

Brazil

Contacts

Public ContactKarin Neppelenbroek

Faculdade de Odontologia de Bauru - Universidade de São Paulo

khnepp@yahoo.com.br+55-014-32358245

Outcome results

None listed

Source: REBEC (via WHO ICTRP)